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      Optimal duration of risperidone or olanzapine adjunctive therapy to mood stabilizer following remission of a manic episode: A CANMAT randomized double-blind trial

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          Abstract

          Atypical antipsychotic adjunctive therapy to lithium or valproate is effective in treating acute mania. Although continuation of atypical antipsychotic adjunctive therapy after mania remission reduces relapse of mood episodes, the optimal duration is unknown. As many atypical antipsychotics cause weight gain and metabolic syndrome, they should not be continued unless the benefits outweigh the risks. This 52-week double-blind placebo-controlled trial recruited patients with bipolar I disorder ( n=159) who recently remitted from a manic episode during treatment with risperidone or olanzapine adjunctive therapy to lithium or valproate. Patients were randomized to one of three conditions: discontinuation of risperidone or olanzapine and substitution with placebo at (i) entry (‘0-weeks' group) or (ii) at 24 weeks after entry (‘24-weeks' group) or (iii) continuation of risperidone or olanzapine for the full duration of the study (‘52-weeks' group). The primary outcome measure was time to relapse of any mood episode. Compared with the 0-weeks group, the time to any mood episode was significantly longer in the 24-weeks group (hazard ratio (HR) 0.53; 95% confidence interval (CI): 0.33, 0.86) and nearly so in the 52-weeks group (HR: 0.63; 95% CI: 0.39, 1.02). The relapse rate was similar in the 52-weeks group compared with the 24-weeks group (HR: 1.18; 95% CI: 0.71, 1.99); however, sub-group analysis showed discordant results between the two antipsychotics (HR: 0.48, 95% CI: 0.17; 1.32 olanzapine patients; HR: 1.85, 95% CI: 1.00, 3.41 risperidone patients). Average weight gain was 3.2 kg in the 52-weeks group compared with a weight loss of 0.2 kg in the 0-weeks and 0.1 kg in the 24-weeks groups. These findings suggest that risperidone or olanzapine adjunctive therapy for 24 weeks is beneficial but continuation of risperidone beyond this period does not reduce the risk of relapse. Whether continuation of olanzapine beyond this period reduces relapse risk remains unclear but the potential benefit needs to be weighed against an increased risk of weight gain.

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          A rating scale for mania: reliability, validity and sensitivity.

          An eleven item clinician-administered Mania Rating Scale (MRS) is introduced, and its reliability, validity and sensitivity are examined. There was a high correlation between the scores of two independent clinicians on both the total score (0.93) and the individual item scores (0.66 to 0.92). The MRS score correlated highly with an independent global rating, and with scores of two other mania rating scales administered concurrently. The score also correlated with the number of days of subsequent stay in hospital. It was able to differentiate statistically patients before and after two weeks of treatment and to distinguish levels of severity based on the global rating.
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            Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI-BP.

            The Clinical Global Impressions Scale (CGI) was modified specifically for use in assessing global illness severity and change in patients with bipolar disorder. Criticisms of the original CGI were addressed by correcting inconsistencies in scaling, identifying time frames for comparison, clarifying definitions of illness severity and change, and separating out assessment of treatment side effects from illness improvement during treatment. A Detailed User's Guide was developed to train clinicians in the use of the new CGI-Bipolar Version (CGI-BP) for rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. The revised scale and manual provide a focused set of instructions to facilitate the reliability of these ratings of mania, depression, and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis. Interrater reliability of the scale was demonstrated in preliminary analyses. Thus, the modified CGI-BP is anticipated to be more useful than the original CGI in studies of bipolar disorder.
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              The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2012 on the long-term treatment of bipolar disorder.

              These guidelines are based on a first edition that was published in 2004, and have been edited and updated with the available scientific evidence up to October 2012. Their purpose is to supply a systematic overview of all scientific evidence pertaining to the long-term treatment of bipolar disorder in adults. Material used for these guidelines are based on a systematic literature search using various data bases. Their scientific rigor was categorised into six levels of evidence (A-F) and different grades of recommendation to ensure practicability were assigned. Maintenance trial designs are complex and changed fundamentally over time; thus, it is not possible to give an overall recommendation for long-term treatment. Different scenarios have to be examined separately: Prevention of mania, depression, or an episode of any polarity, both in acute responders and in patients treated de novo. Treatment might differ in Bipolar II patients or Rapid cyclers, as well as in special subpopulations. We identified several medications preventive against new manic episodes, whereas the current state of research into the prevention of new depressive episodes is less satisfactory. Lithium continues to be the substance with the broadest base of evidence across treatment scenarios. Although major advances have been made since the first edition of this guideline in 2004, there are still areas of uncertainty, especially the prevention of depressive episodes and optimal long-term treatment of Bipolar II patients.
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                Author and article information

                Journal
                Mol Psychiatry
                Mol. Psychiatry
                Molecular Psychiatry
                Nature Publishing Group
                1359-4184
                1476-5578
                August 2016
                13 October 2015
                : 21
                : 8
                : 1050-1056
                Affiliations
                [1 ]Department of Psychiatry, University of British Columbia , Vancouver, BC, Canada
                [2 ]Douglas Hospital, McGill University , Montreal, QC, Canada
                [3 ]Sunnybrook Health Sciences Center, University of Toronto , Toronto, ON, Canada
                [4 ]Bipolar Disorder Program and Laboratory of Molecular Psychiatry, National Institute for Translational Medicine, INCT-TM, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul , Porto Alegre, Brazil
                [5 ]Bipolar Research Program, Department and Institute of Psychiatry, University of São Paulo Medical School , Sao Paulo, Brazil
                [6 ]Department of Psychiatry, Western University , London, ON, Canada
                [7 ]Department of Psychiatry, University Health Network, University of Toronto , Toronto, ON, Canada
                [8 ]Department of Psychiatry, Université de Montréal , Montreal, QC, Canada
                [9 ]Centre for Health Evaluation & Outcome Sciences, St. Paul's Hospital , Vancouver, BC, Canada
                [10 ]Department of Psychiatry, University of Alberta , Edmonton, AB, Canada
                [11 ]Department of Psychiatry, Providence Care, Queen's University , Kingston, ON, Canada
                [12 ]Institut universitaire en santé mentale de Québec , Quebec, QC, Canada
                [13 ]Hospital Universitario de Santa Maria , Santa Maria, Brazil
                [14 ]Laboratory of Neurosciences, Graduate Program in Health Sciences, Health Sciences Unit, University of Southern Santa Catarina , Criciúma, Brazil
                [15 ]Department of Psychiatry, University of Toronto , Toronto, ON, Canada
                [16 ]School of Population & Public Health, University of British Columbia , Vancouver, BC, Canada
                Author notes
                [* ]Department of Psychiatry, University of British Columbia , 2255, Wesbrook Mall, Vancouver, BC V6T 2A1, Canada. E-mail: yatham@ 123456mail.ubc.ca
                Article
                mp2015158
                10.1038/mp.2015.158
                4960445
                26460229
                14b28b11-a605-4ac6-bab9-21cc7491d27c
                Copyright © 2016 Macmillan Publishers Limited

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/

                History
                : 26 June 2015
                : 17 August 2015
                : 08 September 2015
                Categories
                Original Article

                Molecular medicine
                Molecular medicine

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